Malnutrition/micronutrient deficiency is a severe problem in the developing world, impacting 870 million people and causing five million child deaths each year. Attempts to address micronutrient deficiency include supplementation and fortifications. Supplementation can provide higher doses of micronutrients to specific individuals in a short amount of time. However, supplementation has limitations, including inability to deliver all the necessary micronutrients, neglecting individuals in non-targeted groups, and low compliance due to the difficulty in storing product under uncontrolled conditions (hot wet warehouses, poor record keeping), difficulties in distributing supplements and convincing end users of the need for regular ingestion.
Food fortification has been explored as a means for addressing malnutrition/micronutrient deficiency. However, food fortification is often unaffordable to those people who need it most. Adverse effects, such as sensory qualities of foods, adverse nutrient-nutrient interactions, and poor bioavailability, have also been observed in fortified foods.
Salt is a universally consumed product and therefore has the potential to deliver vitamins and minerals to those in developing countries. Fortified salt, also known as iodized salt, is table salt (NaCl) mixed with minute amounts of various salts of iodide, to prevent iodine deficiency. Double fortified salt, which is table salt containing iron and iodide has also been developed. The iron is microencapsulated with stearine to prevent it from reacting with the iodine in the salt. However, adding iron to iodized salt is complicated by a number of chemical, technical, and organoleptic issues, including the tendency of iron to oxide in the presence of air. Salt has also been fortified with potassium fluoride in an attempt to enhance dental health. None of these fortified salts include more labile supplements such as vitamins.
All of these formulations involve physical mixing of salt with one or more minerals. However, as discussed above, the undesirable reactivity between vitamins and minerals and other limitations have prevented commercialization of such formulations. Moreover, these formulations do not provide a plurality of micronutrients and are not stable under conditions encountered during food preparation and cooking.
Kwan describes a fortified salt containing vitamin A, iron, and iodine. The formulation is a physical mixture of salt and forticants. The formulation also contains surfactants and lipids so that the formulation self-emulsifies. Kwan discloses that an attempt was made to enteric coat vitamin A, but losses of the micronutrient after a three month storage period ranged from 50-99% at both 25° C./20% RH and 45° C./60% RH.
Health Salt, sold by Sundar, is a fortified salt containing a plurality of micronutrients, which is allegedly thermally stable. The formulation appears to be a physical mixture of salt and the various micronutrients. Vinodkumar et al., Int. J. Vitam. Nutr. Res., 79(5):348-361 (2009), describes manufacturing a multiple micronutrient-fortified salt in a ribbon blender and evaluating the homogeneity of the distribution of the micronutrients in the salt. However, the product costs 2-3 times more than loose salt, black specks of forticants were observed in the product which may turn off consumers, the product had an unusual odor, and it may be difficult to verify analytically some of the micronutrients in the product.
There exists a need for compositions that provide a plurality of micronutrients in a safe and effective manner while overcoming the limitations of supplementation and fortification discussed above.
Therefore, it is an object of the invention to provide compositions for providing a plurality of heat, moisture and salt labile micronutrients, as well as therapeutic and/or prophylactic agents, and methods of making and using thereof.
It is a further object of the invention to provide compositions for providing a plurality of micronutrients, which are stable during food preparation and cooking, and methods of making and using thereof.
It is a still further object of the invention to provide compositions for providing a plurality of micronutrients, which are stable during food preparation and cooking, and which release the micronutrients at a desired site in the gastrointestinal tract, and methods of making and using thereof.